Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris

NCT07205107 | Active Not Recruiting

• 1 other identifier: BHC-CAN-DERM-004
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 19

Brief Summary

The goal of this observational study is to learn about the effects of a treatment that contains clindamycin phosphate, adapalene, and benzoyl peroxide in people with acne. The main questions the study aims to answer are:

• How satisfied are people with this treatment?
• How well do people follow the treatment plan?
• How effective and safe is the treatment?
• How does the treatment affect quality of life?
• How do people use other skin care products, such as cleansers, moisturizers, and sunscreen, while using this treatment? About 200 people aged 12 and older with acne across Canada will use the treatment as part of their regular care and answer questions about their experience over 20 weeks.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Treatment Satisfaction at Week-12 as assessed by DermSat-7

  To describe treatment satisfaction of clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel at Week-12 in patients with acne vulgaris in Canadian routine clinical practice, using mean DermSat-7 domain scores. The DermSat-7 is a dermatology-specific, 7-item questionnaire used to assess patient satisfaction with treatment across three domains: effectiveness, convenience, and overall satisfaction. Domain scores are transformed to a linear 0-100 scale, with higher scores indicating greater satisfaction.

  Week 12

Secondary Outcomes (9)

• Treatment Satisfaction at Week-4, Week-8 and Week-20 as assessed by DermSat-7

  Week 4, Week 8 and Week 20

• Change from Baseline in Treatment Satisfaction at Week-12 as assessed by DermSat-7

  Baseline and Week-12

• Treatment Adherence at Week-4, Week-8, Week-12, and Week-20

  From Baseline to Week-20

• Treatment Effectiveness as assessed by mean change from baseline in Investigator Global Assessment (IGA) score

  Baseline, Week-12, and Week-20

• Treatment Effectiveness as assessed by mean Investigator Global Assessment (IGA) score

  Baseline, Week-12, and Week-20

Other Outcomes (1)

• Utilization Patterns of Cleanser, Moisturizer, and Sun Protectant

  From Baseline to Week 20

Interventions

clindamycin phosphate, adapalene and benzoyl peroxide DRUG

Topical treatment

Also known as: CABTREO, IDP-126, Clindamycin Phosphate (1.2% w/w), Adapalene (0.15% w/w) and Benzoyl Peroxide (3.1% w/w)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Canadian routine clinical practice

You may qualify if:

• Patients who are 12 years or older (unless minors are not permitted as per local regulations) who have been prescribed clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel as per the product monograph as part of routine clinical care for acne vulgaris but have not yet initiated treatment. The decision to prescribe clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel must be made prior to and independent of study participation.
• Patients and legally authorized representatives who are willing to provide written informed consent using an Institutional Review Board (IRB) or Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) in English or French. Patients who are less than the age of consent must sign an assent for the study and a parent, or a legal guardian must sign the informed consent.
• Patients who can read, understand, and communicate in English or French.
• Patients have completed IRB or IEC-approved baseline ePROs (DermSat-7 and HUI2) after providing consent and prior to receiving their first dose of clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel.
• Patients have initiated clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel within 5 days of signed informed consent/assent.

You may not qualify if:

• Patients who have a contraindication to clindamycin phosphate 1.2% / adapalene 0.15% / benzoyl peroxide 3.1% gel as per the product monograph:
• Patients who are hypersensitive to clindamycin phosphate, to adapalene, to benzoyl peroxide or to any ingredient in the formulation or component of the container,
• Patients with a history of regional enteritis (Crohn's disease), ulcerative colitis, or antibiotic-associated colitis, and/or
• Pregnant women and women planning a pregnancy.
• Patients who, at the time of informed consent, are clear or almost clear (Investigator Global Assessment \[IGA\] = 0 or 1) or are on current acne therapy (topical or systemic, etc.)), or undergoing procedures (e.g., laser, photodynamic therapy) that could impact study results, as per the investigator's judgement.
• Patients who have any other serious and/or uncontrolled medical condition, and/or are receiving any medical therapy, that prohibits the patient from participating as per the investigator's judgement.
• Patients who have whey protein-triggered acne, drug-induced acne, occupational acne, acne associated with hidradenitis suppurativa or synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome, or acne related to hyperandrogenic states including polycystic ovary syndrome (PCOS).
• Patients who have conditions that mimic acne, including rosacea, folliculitis, perioral dermatitis, demodicosis.
• Patients who are not willing or able to complete electronic patient reported outcomes (ePROs) using an electronic device.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (19)

CHARM Site 007

Calgary, Alberta, T2J 7E1, Canada

Location

CHARM Site 001

Edmonton, Alberta, T6W 0J5, Canada

Location

CHARM Site 017

Surrey, British Columbia, V3V 0C6, Canada

Location

CHARM Site 012

Vancouver, British Columbia, V5Z 1H2, Canada

Location

CHARM Site 003

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

CHARM Site 021

Hamilton, Ontario, L8P 4B4, Canada

Location

CHARM Site 010

Markham, Ontario, L3P 1X3, Canada

Location

CHARM Site 013

Newmarket, Ontario, L3Y 5G8, Canada

Location

CHARM Site 022

North York, Ontario, M3B 0A7, Canada

Location

CHARM Site 015

Ottawa, Ontario, K1V 7Z5, Canada

Location

CHARM Site 011

Richmond Hill, Ontario, L4B 1L1, Canada

Location

CHARM Site 016

Toronto, Ontario, M2N 3A6, Canada

Location

CHARM Site 005

Toronto, Ontario, M4E 1R7, Canada

Location

CHARM Site 014

Toronto, Ontario, M4W 2N2, Canada

Location

CHARM Site 002

Toronto, Ontario, M5A 3R6, Canada

Location

CHARM Site 019

Windsor, Ontario, N8W 5L7, Canada

Location

CHARM Site 008

Montreal, Quebec, H1Y 3L1, Canada

Location

CHARM Site 006

Pointe-Claire, Quebec, H9R 5M7, Canada

Location

CHARM Site 018

Québec, Quebec, G1W 4R4, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

clindamycin phosphate; Adapalene; Benzoyl Peroxide

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives

Study Officials

• Veronique Gaudet

  Bausch Health, Canada Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 3, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

CA (19)